Biomerieux Inc: Medical Device Recall in 2014 - (Recall #: Z-1177-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.

Product Classification:

Class II

Date Initiated: February 10, 2014

Date Posted: March 19, 2014

Recall Number: Z-1177-2014

Event ID: 67463

Reason for Recall:

The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.

Status: Terminated

Product Quantity: 471 instruments

Code Information:

Serial number range: AS 180-00001 to AS 180-00476

Distribution Pattern:

Distribution was made to AK, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated